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Comparison of Prostate Cancer-related Quality of Life in Sexually Active Men With Favourable Intermediate-risk Localised Prostate Cancer Treated With Total Prostatectomy or Focal HIFU (QUALIFY)

G

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Begins enrollment this month

Conditions

Prostate Cancer

Treatments

Procedure: Total prostatectomy
Procedure: Focal HIFU

Study type

Interventional

Funder types

Other

Identifiers

NCT06945172
2024-A02716-41 (Other Identifier)

Details and patient eligibility

About

The goal of this trial is to assess the impact of focal HIFU therapy on quality of life in patients with favourable intermediate-risk localised prostate cancer. The main question it aims to answer is:

What is the prostate cancer-related quality of life in patients with favourable intermediate-risk localised cancer treated by total prostatectomy or focal HIFU ?

Researchers will compare patients with favourable intermediate-risk localised cancer treated by total prostatectomy to patients with favourable intermediate-risk localised cancer treated by focal HIFU to see their quality of life.

Participants will answer EPIC-CP questionnaire 6 months, 12 months and 24 months after treatment

Enrollment

102 estimated patients

Sex

Male

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient, male, aged between ≥ 40 and ≤ 75 years
  • Patient with a life expectancy > 10 years at the time of inclusion.
  • Patient with a therapeutic strategy (prostatectomy or focal HIFU) defined during a PCR.
  • Patient with a diagnosis of localised prostate cancer at favourable intermediate risk
  • Patient able to tolerate general anaesthesia or type IV sedation
  • Patient with normal urinary continence status
  • Patient with satisfactory erectile function allowing penetration:
  • Patient with targeted biopsies and systematic biopsies
  • Patient affiliated to or benefiting from a social security scheme
  • French-speaking patients who do not object to the use of their data.

Exclusion criteria

  • Patients with a contraindication to MRI
  • Stage T3a or b on MRI
  • Patient on long-term anticoagulants and unable to stop them.
  • Patient already included in another study
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

Total prostatectomy
Active Comparator group
Description:
Patient will undergo total prostatectomy as a treatment for their cancer
Treatment:
Procedure: Total prostatectomy
Focal HIFU
Experimental group
Description:
Patient will undergo focal HIFU as a treatment for their cancer
Treatment:
Procedure: Focal HIFU

Trial contacts and locations

1

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Central trial contact

Guillaume PLOUSSARD, MD

Data sourced from clinicaltrials.gov

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